Patent Overview

 

Our patents disclose a method for isolating and preparing an inactive pepsin fraction (IPF) useful for detecting and treating HIV-1 infection and some autoimmune and viral diseases. Extensive research indicates that IPF can open the window for the creation of therapeutic vaccines for diseases such as HIV, cancer and hepatitis without the drawbacks of similar well-known compositions. Following is some more specific information on IPF’s application to each of these diseases.

HIV

IPF shows great promise in treating HIV infections while overcoming the cost, toxicity, compliance and drug resistance of existing treatments.  The IPF based vaccine has been studied as a salvage therapy on stage CDC-3 AIDS patients using a mono approach. The results of four non-US experimental trials on 200 patients show the action and effectiveness of the vaccine. Immunological results are;

  1. Increase in percentages and numbers of CD8 and CCR5 positive cells in the treated patients.
  2. Significant increase in CD8+, CD38+ cells in the treated patients.
  3. Significant increase in both CD4+ iNFg, secreting cells in the treated patients.

Previously under license to Immunotech Labs for the HIV market, IPF when formulated into a vaccine demonstrated in preliminary trials gp41 and gp120 bound together through alpha-1 and alpha-2 and beta-serum fractions, which when formed inside the body blocks direct HIV-CD4 contact and also triggers an immune reaction.

An essential element of this approach is using combinations of known and new immune-creators with gp41 and gp120 antigens in order to increase their immunogenicity. This approach using the vaccine as an immune-creator results in creating a complex antigen having the properties of a vaccine.

IPF has demonstrated advantages over traditional HIV treatments including:

  • Significantly fewer and milder side effects
  • Minimal toxicity
  • Does not cause viral mutation
  • Requires only a short treatment cycle
  • Enhances the immune system and enhances quality of life
  • Cost effectiveness
  • Simple and short treatment modality without compliance issues
  • Treatment of drug resistant  patients

Cancer

Our patents disclose a method for isolating and preparing an inactivated pepsin fraction (IPF) useful for detecting and treating cancers. One of the major goals of immune therapy is to harness a patient’s immune system against tumor cells.    The technology developed over some ten years by Zhabilov, involves treatment to increase the immunogenicity of cancer cells.  This immunogenicity leads to an induction of anticancer immune response, more especially, cancer specific T cells responses.  IPF increases levels of interference (IFNs).  Clear demonstrations are available of increased immunogenicity of treated melanoma cells.  Immunogenicity of the vaccine is further enhanced through the inclusion of proprietary adjuvant IL2.  This adjuvant acts to protect the immune cells activated in response to the vaccine.  This protection increases survival and prolongs the post vaccine immune response.

With regard to cancer therapy the objective is to direct the patient’s immune system against tumor cells by targeting antigens that are associated with tumor cells, but not normal counterparts.  These tumor associated antigens (TAAs) have been difficult to identify.  Certain tumor cells express antigens that are normally not expressed, or expressed at very low levels in the healthy cells.  One example is an alpha-fetoprotein, which is expressed by liver cancer cells.  Another onco fetal tumor antigen is carcinoembrionic antigen (CII) which is expressed in adenocarcinomas of the digestive system.  Unfortunately the immune system cannot recognize specific tumor antigens and reject the tumor.  Recent advances of our understanding have revealed that any proteins binding with specific tumor antigens can be recognized by the immune system.  Attached proteins by the tumor antigens form super antigens which will increase production of antibody against the tumor cells.  Amplification of immune response will be using different kinds of cytokines.

A complex of inactivated pepsin fraction (IPF) component and gp96 peptide is a method of modulating immune system activity by inducing specific T cells (CTL) response against tumor cells.  Gp96 also delivers maturation signals to the DC, and includes the expression of MHC antigen.  The ability of gp96 to transfer antigen peptides/MHC to initiate T cell mediated anti-tumor responses and uptake and processing of tumor antigens by DC, makes it an ideal candidate for triggering an immune responses in an organism in response to tumor.  It could be assumed that gp96 is binding by the immune system and this new super antigen stimulates immune responses using a non conventional antigen processing pathway.  IPF is a sterile biological product.  It is isolated pepsin enzyme by buffer extraction and cleavage.  The following have been demonstrated in several experiment studies:

  1. Increased CD8 and, IFN gamma
  2. Increased CD8 number over time
  3. Improved cellular response of both CD4 and CD8 when activated in vitro by nonspecific mitogens.

Hepatitis

Our patents disclose a method for isolating and preparing an inactivated pepsin fraction (IPF) useful for detecting and treating HIV1 HCV and some autoimmune and viral diseases.  According to preliminary trials the complex antigen of IPF and viral antigens together through Alfa 1, Alfa 2 and beta serum fractions which form inside the body, blocks contact virus and hepatocytes and immune cells  while at the same time trigger an immune reaction.  The new antigen complex triggers an immune reaction model with the participation of T lymphocytes with gamma-delta chains on their surface.  In this way, IPF appears like an immune creator and can be used for treatment of HCV infection.  This approach, using IPF as an immune creator results in creating a complex antigen having the properties of a vaccine.  The new antigen complex triggers an immune reaction model with the participation of T lymphocytes.  The results of the pilot testing study conducted clearly show the action and effectiveness of IPF.  Immunological results by Dr. Santos from Centro Medico Nova in Mexico are:

  1. Increase in percentage and numbers of CD8 positive cells in the treated patients
  2. Significant decline CD8+CD38+cells in treated patients
  3. Significant increase in both the CD4+iNFg secreting cells as well as the CD8+iNFg secreting cells in the treated patients
  4. Increase all the cytokines such as IL2 IL6 IL12 relate with the TH1 immune response

All of the above immunological changes show the immunological effect of IPF.  The demonstrated immunological results can open a window for the creation of vaccine treating against viral diseases such as HCV.

The specific assets currently being offered for sale or license include:

  • US Patent 7, 479,538 Irreversibly-inactivated pepsinogen fragment and pharmaceutical compositions comprising the same for detecting, preventing, and treating HIV
  • PCT/US05/45515 International counterpart to US 7,479,538
  • US application 12/487/637 Irreversibly-inactivated pepsinogen fragments for modulating immune function via isolated anti-cancer peptides
  • US application 12/315,441 Inactivated Pepsin fragments for modulating immune system activity again human malignant tumor cells
  • US application 12/321,262 Irreversibly-inactivated pepsinogen fragment and pharmaceutical compositions comprising the same for detecting, preventing and treating HIV

Additional information is available on the background research and various applications of IPF including details of the HIV and oncology clinical trials that have been conducted.

For additional information: Patent Value Report